Not Yet RecruitingNot Applicable

tDCS for Catatonic Depression in Down Syndrome: A Pilot Study

62 participantsStarted 2025-09-12

Plain-language summary

This study evaluates the efficacy of transcranial direct current stimulation (tDCS) for depression with catatonia in individuals with Down syndrome (DS). 62 patients will be randomized to receive 15 sessions of active or sham tDCS. The primary objective is to measure changes in depressive/catatonic symptoms using the Bush-Francis Catatonia Rating Scale (BFCRS). Secondary objectives include safety, cognitive effects, EEG correlates, and biological markers (cortisol, BDNF, cytokines). The study aims to provide a non-pharmacological therapeutic alternative for this population

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient with Down syndrome * Age \> 18 * Diagnosis of Major Depressive Disorder MDD with catatonic symptoms according to the DSM-5 criteria * Informed consent signed by the patient, by the patient under curatorship, or by the legal representative in the case of a patient under guardianship. * Person affiliated to the French social security system or equivalent Exclusion Criteria: * Pregnancy (checked with a pregnancy test) * Contraindication for tDCS(i.e., cochlear implant) * Refusal of the patients or their legal representatives * Other persons protected under the CSP (judicial safeguard, family habilitation)

What they're measuring

Acute changes on depressive / catatonic symptoms between D0 and D5 measured with the Bush-Francis Catatonia Rating Scale (BFCRS)

Timeframe: 27 months

Trial details

NCT IDNCT06866925

SponsorHôpital le Vinatier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-01

Contact for this trial

JEROME J BRUNELIN, PhD, HDR)

00334 37 91 54 95 jerome.brunelin@ch-le-vinatier.fr